Acute PainPhase 2AcuMAPNCT02460913
Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department
A Phase 2 study testing Acupuncture and Morphine titration in people with Acute Pain, run by University of Monastir.
Trial summary
Inadequate pain management is a common problem encountered in ED settings. Pain relief medications use is often limited by their side effects. Evidence suggests that non pharmacologic pain relief techniques such as acupuncture can play a central role to treat pain in acute conditions, but their application is still… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Acupuncture and Morphine titration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute onset pain < 72 hours of the ED presentation
- Pain intensity ≥ 40 of the VAS or NRS (ranging from 0 for no pain to 100 for maximum imaginable pain)
- Acute musculoskeletal pain with no evidence of fracture or dislocation, including ankle and knee sprains without signs of severity (ligament rupture, laxity), shoulder and elbow tendinitis, upper and lower limb mechanical pains and lower back pain with no evidence of neurological deficit.
- Acute abdominal pain with no urging surgical intervention including renal colic and dysmenorrhea.
- Acute headache that meets the criteria of primary headache, as described by the international headache society.
Who cannot join
- Temperature > 37.7°c
- Violent mechanism of trauma
- Patients under anticoagulant drugs or with coagulation abnormalities
- Skin affections (infections, hematoma, dermatosis) that would impair the use of certain acupuncture points
- Patients that were judged enable to participate in the study at the discretion of the treating physician.
- Refusal, inability to consent.
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- Inability to assess the degree of pain using the VAS or NRS
- Patients who had received analgesics in the 6 hours prior to the enrollment
- An initial pain score ≤ 40 on the VAS or NRS
- Patients who had presented to the ED in the last 24 hours with the same motif
- Pregnancy
About this study
Official title: Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department. An Efficacy and Safety Study
Inadequate pain management is a common problem encountered in ED settings. Pain relief medications use is often limited by their side effects. Evidence suggests that non pharmacologic pain relief techniques such as acupuncture can play a central role to treat pain in acute conditions, but their application is still scarce.
Read the detailed description
Pain is a common cause of emergency department visits and its control remains a challenge and health priority worldwide. Many techniques were developed to control pain and to ensure patients comfort but their application is still difficult especially in emergency department (ED) settings, due to the variety of treated conditions, the non-availability of qualified practitioners and the patient's specificity. Pharmacologic methods in particular IV opioids are the most used and with regard to their rapid action with high efficacy. But the use of these drugs can be limited by their side effects. Non-pharmacologic pain relief techniques such as acupuncture have been proposed. During the second half of the twentieth century, acupuncture was established in Europe and in the last two decades, it has spread around the world. In Tunisia, acupuncture was introduced into the health system in the 90s, particularly to treat pain.
The World Health Organization (WHO) has recognized acupuncture as safe and sound therapy. A preliminary list of acupuncture indications has been reported including 43 diseases. However, the introduction of acupuncture in the treatment of pain in ED is more recent or even anecdotal. In the treatment of chronic pain, it was shown that acupuncture is comparable to morphine and that its better safety profile makes it the method of choice in some clinical conditions.
In a recent systematic review, it has been concluded that there is insufficient evidence for the use of acupuncture in the ED settings due to the paucity of randomized controlled trials and the suboptimal methodological qualities of related studies.
The aim of our study was to evaluate the efficacy and safety of acupuncture compared with morphine for the management of acute pain in ED.
- Conditions
- Acute Pain
- Being tested
- Acupuncture, Morphine titration
- Keywords
- acupuncture, morphine, acute pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Acupuncture session of 20 to 30 minutes. Treatment protocols were determined through review of major clinical manuals and textbooks, literature review, and a panel of specialist acupuncturists from Chinese medicine backgrounds.
Morphine titrationDrug
Also called Morphine
Patients in this group received IV titrated morphine. Morphine was prepared onsite and diluted in a manner to obtain a dose of 1mg in each ml of normal saline. The initial dose was 0.1 mg per kg and a titration dose of 0.05 mg per Kg was repeated every 5 minutes until reaching objective. The maximum allowed dose was 1.5 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | patients received a 20 to 30 minutes session of acupuncture Receives: Procedure: Acupuncture |
| IV Morphine | Active comparator | patients received an intravenous titration of morphine every 5 minutes. Receives: Drug: Morphine titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pain severity from baseline
Change of pain score was assessed at 10, 20, 30, 45 and 60 minutes time points from the starting of the protocol.
Pain severity was measured using the visual analogic scale (VAS) going from 10 (maximum imaginable pain) to 0 (no pain). if the VAS was not applicable to certain patients, a verbal numeric rating scale (NRS) was used instead.
Success of treatment was defined by a drop in the pain intensity under 30.
Measured: 10, 20, 30, 45, 60 minutes
Secondary outcomes (2)
resolution time
This interval was defined by the time (in minutes) elapsed between the start of the protocol (T0) and the decrease of the pain score of at least 50% of its initial value.
Measured: 10, 20, 30, 45, 60 minutes
adverse events
Occurrence of major side effects implicates the immediate ending of the protocol, more particularly:
- Allergic manifestations such as rush and generalized edema
- severe hypotension defined by a drop of the systolic blood pressure under 90 mmHg or a loss of more than 20 mmHg of the initial systolic blood pressure
- recurrent vomiting non controlled by the standard measures
- Altered mental status
- Uncontrolled bleeding from the site of needle insertion
- Respiratory distress with capillary saturation under 95% or signs of pneumothorax
Measured: 10, 20, 30, 45, 60 minutes and until ED discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startApr 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- nouira semir, MD, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460913
- Sponsor's protocol ID
- 13/02
- Acronym
- AcuMAP
- Status last verified
- Feb 2020
- First submitted
- 25 May 2015
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim KH, Lee BR, Ryu JH, Choi TY, Yang GY. The role of acupuncture in emergency department settings: a systematic review. Complement Ther Med. 2013 Feb;21(1):65-72. doi: 10.1016/j.ctim.2012.12.004. Epub 2012 Dec 29.
PubMed 23374207Cohen M, Parker S, Taylor D, Smit de V, Ben-Meir M, Cameron P, Xue C. Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: study protocol for a randomized controlled trial. Trials. 2011 Nov 15;12:241. doi: 10.1186/1745-6215-12-241.
PubMed 22085683
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department. An Efficacy and Safety Study
- ClinicalTrials.gov ID
- NCT02460913
- Acronym / sponsor ID
- AcuMAP / 13/02
- Conditions
- Acute Pain
- Keywords
- acupuncture, morphine, acute pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inadequate pain management is a common problem encountered in ED settings. Pain relief medications use is often limited by their side effects. Evidence suggests that non pharmacologic pain relief techniques such as acupuncture can play a central role to treat pain in acute conditions, but their application is still scarce.
Detailed description
Pain is a common cause of emergency department visits and its control remains a challenge and health priority worldwide. Many techniques were developed to control pain and to ensure patients comfort but their application is still difficult especially in emergency department (ED) settings, due to the variety of treated conditions, the non-availability of qualified practitioners and the patient's specificity. Pharmacologic methods in particular IV opioids are the most used and with regard to their rapid action with high efficacy. But the use of these drugs can be limited by their side effects. Non-pharmacologic pain relief techniques such as acupuncture have been proposed. During the second half of the twentieth century, acupuncture was established in Europe and in the last two decades, it has spread around the world. In Tunisia, acupuncture was introduced into the health system in the 90s, particularly to treat pain.
The World Health Organization (WHO) has recognized acupuncture as safe and sound therapy. A preliminary list of acupuncture indications has been reported including 43 diseases. However, the introduction of acupuncture in the treatment of pain in ED is more recent or even anecdotal. In the treatment of chronic pain, it was shown that acupuncture is comparable to morphine and that its better safety profile makes it the method of choice in some clinical conditions.
In a recent systematic review, it has been concluded that there is insufficient evidence for the use of acupuncture in the ED settings due to the paucity of randomized controlled trials and the suboptimal methodological qualities of related studies.
The aim of our study was to evaluate the efficacy and safety of acupuncture compared with morphine for the management of acute pain in ED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: Acupuncturepatients received a 20 to 30 minutes session of acupuncture |
| IV Morphine | Active comparator | Drug: Morphine titrationpatients received an intravenous titration of morphine every 5 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute onset pain < 72 hours of the ED presentation
- Pain intensity ≥ 40 of the VAS or NRS (ranging from 0 for no pain to 100 for maximum imaginable pain)
- Acute musculoskeletal pain with no evidence of fracture or dislocation, including ankle and knee sprains without signs of severity (ligament rupture, laxity), shoulder and elbow tendinitis, upper and lower limb mechanical pains and lower back pain with no evidence of neurological deficit.
- Acute abdominal pain with no urging surgical intervention including renal colic and dysmenorrhea.
- Acute headache that meets the criteria of primary headache, as described by the international headache society.
Key exclusion criteria (11 listed)
- Temperature > 37.7°c
- Violent mechanism of trauma
- Patients under anticoagulant drugs or with coagulation abnormalities
- Skin affections (infections, hematoma, dermatosis) that would impair the use of certain acupuncture points
- Patients that were judged enable to participate in the study at the discretion of the treating physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture session of 20 to 30 minutes. Treatment protocols were determined through review of major clinical manuals and textbooks, literature review, and a panel of specialist acupuncturists from Chinese medicine backgrounds. | Procedure or surgery | Acupuncture |
| Morphine titrationAlso: MorphinePatients in this group received IV titrated morphine. Morphine was prepared onsite and diluted in a manner to obtain a dose of 1mg in each ml of normal saline. The initial dose was 0.1 mg per kg and a titration dose of 0.05 mg per Kg was repeated every 5 minutes until reaching objective. The maximum allowed dose was 1.5 mg/kg. | Drug | IV Morphine |
Primary outcome
change of pain severity from baseline
Time frame: 10, 20, 30, 45, 60 minutes
Change of pain score was assessed at 10, 20, 30, 45 and 60 minutes time points from the starting of the protocol. Pain severity was measured using the visual analogic scale (VAS) going from 10 (maximum imaginable pain) to 0 (no pain). if the VAS was not applicable to certain patients, a verbal numeric rating scale (NRS) was used instead. Success of treatment was defined by a drop in the pain intensity under 30.
2 secondary outcomes
resolution time
Time frame: 10, 20, 30, 45, 60 minutes
adverse events
Time frame: 10, 20, 30, 45, 60 minutes and until ED discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Background: PubMed 23374207Kim KH, Lee BR, Ryu JH, Choi TY, Yang GY. The role of acupuncture in emergency department settings: a systematic review. Complement Ther Med. 2013 Feb;21(1):65-72. doi: 10.1016/j.ctim.2012.12.004. Epub 2012 Dec 29.
- Background: PubMed 22085683Cohen M, Parker S, Taylor D, Smit de V, Ben-Meir M, Cameron P, Xue C. Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: study protocol for a randomized controlled trial. Trials. 2011 Nov 15;12:241. doi: 10.1186/1745-6215-12-241.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nouira semir, MD principal investigator
University of Monastir
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture and Morphine titration in people with Acute Pain, run by University of Monastir.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of pain severity from baseline (time frame: 10, 20, 30, 45, 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02460913, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.